SolfVue

System, Imaging, Pulsed Echo, Ultrasonic

DELPHINUS MEDICAL TECHNOLOGIES, INC

The following data is part of a premarket notification filed by Delphinus Medical Technologies, Inc with the FDA for Solfvue.

Pre-market Notification Details

Device IDK142517
510k NumberK142517
Device Name:SolfVue
ClassificationSystem, Imaging, Pulsed Echo, Ultrasonic
Applicant DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth,  MI  48170
ContactAndrea N Wallen-gerding
CorrespondentAndrea N Wallen-gerding
DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth,  MI  48170
Product CodeIYO  
CFR Regulation Number892.1560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-08
Decision Date2014-10-31
Summary:summary

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